RecruitingNot ApplicableNCT04097145

Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients With Tricuspid Regurgitation

Sponsor

Edwards Lifesciences

Enrollment

1,270 participants

Start Date

Dec 11, 2019

Study Type

INTERVENTIONAL

Conditions

Tricuspid Regurgitation Tricuspid Valve Insufficiency Tricuspid Valve Disease

Summary

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This pivotal clinical trial studies the Edwards PASCAL device — a catheter-based (minimally invasive) repair system for people with severe tricuspid regurgitation, a leaky valve on the right side of the heart. The PASCAL device is delivered through a vein rather than open heart surgery. You may be eligible if: - You are 18 years old or older - You have severe or greater tricuspid regurgitation despite medical therapy - You have NYHA Class II-IVa heart failure or were hospitalized for heart failure in the past year - Your surgical risk is estimated as intermediate or greater - You are able to follow study requirements and attend follow-up visits You may NOT be eligible if: - Your tricuspid valve anatomy cannot be assessed by echocardiogram or is unsuitable for this device - You have Stage D (end-stage) heart failure requiring a ventricular assist device or heart transplant - You have a pacemaker lead that would interfere with the device - You are pregnant, breastfeeding, or planning pregnancy within 12 months - You have active endocarditis, recent stroke, or life expectancy under 12 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEdwards PASCAL System

Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy

DRUGOptimal Medical Therapy

Optimal Medical Therapy alone in patients with tricuspid regurgitation

DEVICEEdwards PASCAL System

Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT

DEVICEEdwards PASCAL System

Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation

Locations(79)

Banner University Medical Center Phoenix

Phoenix, Arizona, United States

Tucson Medical Center Healthcare

Tucson, Arizona, United States

University of California, Irvine

Irvine, California, United States

SCPMG - Kaiser San Diego

La Jolla, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

UCLA Medical Center

Los Angeles, California, United States

Kaiser Permanente San Francisco

San Francisco, California, United States

University of California, San Francisco

San Francisco, California, United States

Stanford University

Stanford, California, United States

St. Joseph Hospital

Denver, Colorado, United States

Medical Center of the Rockies

Loveland, Colorado, United States

The Cardiac and Vascular Institute Research Foundation

Gainesville, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

NCH Healthcare System

Naples, Florida, United States

Sarasota Memorial Health Care System

Sarasota, Florida, United States

Tallahassee Research Institute

Tallahassee, Florida, United States

Emory University Hospital Midtown / Emory University - St. Joseph's Hospital

Atlanta, Georgia, United States

Piedmont Healthcare, Inc.

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Ascension St. Vincent Heart Center Cardiovascular Research Institute

Indianapolis, Indiana, United States

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Johns Hopkins

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

William Beaumont Hospital - Royal Oak

Royal Oak, Michigan, United States

St. Mary's of Ascension Research

Saginaw, Michigan, United States

Fairview Health Services

Maplewood, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Providence St. Patrick Hospital

Missoula, Montana, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Cooper Health Systems

Camden, New Jersey, United States

Morristown Medical Center

Morristown, New Jersey, United States

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

State University of New York at Buffalo

Buffalo, New York, United States

Columbia University Irving Medical Center/NYPH

New York, New York, United States

Weill Cornell Medicine

New York, New York, United States

Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset

New York, New York, United States

Rochester General Hospital

Rochester, New York, United States

St. Francis Hospital

Roslyn, New York, United States

Montefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses Hospital

The Bronx, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Sanford Medical Center Fargo

Fargo, North Dakota, United States

The Christ Hospital

Cincinnati, Ohio, United States

TriHealth-Bethesda North Hospital

Cincinnati, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Integris Baptist Medical Center

Oklahoma City, Oklahoma, United States

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, United States

Oklahoma Heart Institute at Hillcrest Medical Center

Tulsa, Oklahoma, United States

Oregon Health & Science University

Portland, Oregon, United States

Penn State Hershey

Hershey, Pennsylvania, United States

Pennsylvania Presbyterian Medical Center / Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Pinnacle Health Cardiovascular Institute/UPMC Pinnacle

Wormleysburg, Pennsylvania, United States

Lankenau Heart Institute

Wynnewood, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Erlanger Health System

Chattanooga, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

HCA Houston Healthcare Medical Center

Houston, Texas, United States

Baylor College of Medicine St. Luke's Medical Center

Houston, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

UTHealth/Memorial Hermann Hospital

Houston, Texas, United States

Baylor Scott & White - The Heart Hospital - Plano

Plano, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

St. George Regional Hospital

St. George, Utah, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Carilion Medical Center

Roanoke, Virginia, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Swedish Medical Center

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

St. Paul's Hospital

Vancouver, British Columbia, Canada

Hamilton Health Services

Hamilton, Ontario, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Québec, Quebec, Canada

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NCT04097145

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